510(k) K220584 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
BD Cathena Safety IV Catheter
| Applicant | Becton Dickinson Infusion Therapy Systems, Inc., Sandy UT, US |
| Decision | Substantially Equivalent, Mar 31, 2022 |
| Received | Mar 1, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K220584
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 21, 2025 | Becton Dickinson Infusion Therapy Systems, Inc. BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865;
BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC, REF: 386803;
BD Cathena Safety IV Catheter BD Multiguard Te Open, Classified |
FOZ | None listed |
| Oct 3, 2023 | Becton Dickinson Infusion Therapy Systems Inc. REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO Open, Classified |
FOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.